Working Memory Training for People Aging With HIV

NCT06699927 | Completed Early Phase 1

• 1 other identifier: NU-20241107
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The present study investigates the feasibility of working memory training in people aging with HIV (PAWHIV). In a cross-over design this stage 1 feasibility trial, will evaluate acceptability, and estimate possible effect sizes related to working memory training by examining potential differential effects in PAWHIV and those aging without HIV. This project highlights the importance of tailored cognitive assessments and interventions, engaging with underrepresented communities to enhance inclusivity in cognitive health research.

Conditions

Cognitive Change

Outcome Measures

Primary Outcomes (2)

• Change in Everyday Memory Questionnaire Revised

  The Everyday Memory Questionnaire Revised (Royle \& Lincoln, 2008) consists of 13 items that describe everyday events that might involve forgetting. Participants are asked how often on average they think each one has happened to them over the past month on a 5-point scale (0-4) and the total score is calculated as the sum of all responses. The minimum total score is 0 and the maximum is 52, with higher scores indicative of greater presence of memory difficulties. The outcome measure is the change in total score at the point of measurement compared to baseline at Day 1.

  Day 24, Day 46, Day 77

• Change in General Cognitive Ability Composite Score

  A composite score will be generated by taking the average of standardized outcome measures on tasks in the Standard Older Adult Cognitive Battery (SOACB), which consists of word list learning, complex figure copy, object naming, trail making, a vocabulary task, and matrix reasoning. The outcome measure is the change in the composite score reached on the task compared to baseline at Day 1.

  Day 77

Secondary Outcomes (6)

• Change in Inhibitory Control Composite Score

  Day 24, Day 46, Day 78

• Training Experience Enjoyment

  Day 24, Day 46

• Training Experience Subjective Progress

  Day 24, Day 46

• Training Experience Satisfaction Scale

  Day 24, Day 46

• Training Experience Difficulty Scale

  Day 24, Day 46

Study Arms (2)

Non-gamified First

ACTIVE COMPARATOR

Training type 1 will be administered in the first part of the crossover trial and Training type 2 will be administered in the second part of the trial. Each training part consists of 20 twenty-minute long sessions with the recommended frequency of 2 sessions per work day. Thus each training part can be completed in 10 work days (2 weeks).

Behavioral: Span

Gamified First

ACTIVE COMPARATOR

Training type 2 will be administered in the first part of the crossover trial and Training type 1 will be administered in the second part of the trial. Each training part consists of 20 twenty-minute long sessions with the recommended frequency of 2 sessions per work day. Thus each training part can be completed in 10 work days (2 weeks).

Behavioral: Span

Interventions

Span BEHAVIORAL

The training program is a personal device-based adaptive version of a visual working memory span task, either devoid of game elements or embedded in a gamified platform game

Gamified First; Non-gamified First

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Able to understand and speak English and follow study procedures
• Does not have a psychological or neurological condition that would prevent being able to give consent to participate
• Not currently involved in any other cognitive or memory training studies

You may not qualify if:

• Formal diagnosis of dementia or other neurological disease, including Mild cognitive impairment.
• A final total score below 17 on Montreal Cognitive Assessment - Blind (telephone) version.
• Score of 10 or more on the Generalized Anxiety Questionnaire (GAD7; Spitzer et al., 2006, Archives of Internal Medicine), indicating presence of moderate or severe anxiety
• Score of 9 or more on Geriatric depression scale (GDS15; Yesavage et al., 1982) indicating presence of moderate or severe depression
• Abnormal visual acuity prohibitive of tablet-based training.
• Physical handicap (motor or perceptual) that would impede training procedures.
• Medical illness requiring treatment and/or significant absences during the study timeline.
• Current evidence or 2-yr history of seizures, focal brain lesion, or head injury with loss of consciousness.
• Current alcohol consumption exceeds 14 drinks per week.
• Self-reported illicit drug use.

Sponsors & Collaborators

• Northeastern University: lead

Study Sites (1)

Northeastern University

Boston, Massachusetts, 02115, United States

Location

Study Officials

• Susanne Jaeggi, PhD

  Northeastern University

  PRINCIPAL INVESTIGATOR

• Aaron Seitz

  Northeastern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized crossover trial will be conducted and participants will be randomly assigned to 1 of 2 conditions: Condition 1 consists of training type 1 followed by training type 2, whereas Condition 2 consists of training type 2 followed by training type 1. They will be assigned to Non-Gamified Span training and Gamified Span training.

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 21, 2024
• Study Start: July 15, 2024
• Primary Completion: March 6, 2026
• Study Completion: March 6, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available persistently at the conclusion of the study.
• Access Criteria: There are no access criteria

Locations

US (1)